Integrated medical writing across development, regulatory, publications and safety

Biostellaar provides integrated medical writing support across clinical development, regulatory documentation, scientific publications and pharmacovigilance-related activities.

Our services

Three practice areas, one accountable writing partner

01

Medical & Regulatory Writing

Clinical and regulatory documents developed across the drug development lifecycle.

  • Clinical Study Reports (CSRs)
  • Patient and safety narratives
  • Investigator’s Brochures (IBs)
  • Clinical trial protocols
  • Clinical and regulatory summaries
  • Regulatory briefing documents
  • CTD-related documentation and modules
  • Regulatory responses and supporting documents
  • Clinical trial disclosure documentation
Medical & regulatory writing
02

Safety & Pharmacovigilance Writing

Safety documentation prepared clearly, consistently and in line with applicable requirements.

  • DSUR
  • PBRER
  • PADER / PSUR-related documentation
  • Risk Management Plan (RMP) writing support
  • Safety narratives and case summaries
  • Pharmacovigilance-related reports and summaries
  • Literature and safety-related medical writing support
Pharmacovigilance writing
03

Publications & Scientific Communications

Manuscripts and communication materials that present scientific findings accurately.

  • Original research manuscripts
  • Review articles
  • Case reports and case series
  • Systematic and literature reviews
  • Abstracts
  • Posters
  • Scientific presentations
  • Journal selection and submission support
  • Manuscript editing, formatting and revision support
Publication services
Flexible engagement models

Engage Biostellaar the way your programme needs

Clients can engage Biostellaar for individual documents, defined project work, ongoing writing support or additional capacity during peak workloads.

Individual documents

Engage us for a single deliverable — one CSR, one manuscript, one periodic safety report.

Defined project work

A scoped package of documents with agreed deliverables, milestones and timelines.

Ongoing writing support

Continuous medical writing capacity aligned to your programme as it progresses.

Peak-workload capacity

Additional writing resource when submission deadlines or workload peaks demand it.

Next step

Not sure which service you need?

Share your document type, therapeutic area and timeline. We will review the requirement and recommend the right scope and engagement model.